A Prospective, Multicenter, Open Label, Phase IV Clinical Trial to Test Efficacy and Safety of Highly Purified Human Chorionic Gonadotropin For Inducing Final Follicular Maturation in Assisted Reproductive Technique(ART) - HuCoG-HP

Bharat Serums and Vaccines Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Subject undergoing ovulation induction with injectable gonadotropins with least 1 follicle >= 18 mm in size.
•2. Subject aged >20 or <40 (Both inclusive)
•3. BMI between 18 and 30 kg/m2.
•4. Normogonadotrophic subjects with normal hormonal profile.
•5. Male partner with semen parameters compatible with ART using ejaculated sperm.
•6. Normal Uterine cavity and at least one normal tube confirmed on 3D US and Hystero Contrast Salpingogram (HycoSy) or hystosalpingogram (HSG) &/or Laparoscopy within 3 years before recruitment.
•7. Transvaginal ultrasound documenting the presence of both ovaries, without evidence of abnormality (e.g. no endometrioma)and normal adnexa (e.g. no hydrosalphinx) within 6 months before recruitment.
•8. Signed informed consent form before screening

•1. Subject 20 or 40 years of age.
•2. Infertility attributable to severe endometriosis (grade III or IV).
•3. Subjects whose male partner needs surgical sperm retrieval.
•4. Pelvic pathology that would compromise ART success.
•5. Any chronic systemic disease including uncorrected hyperthyroid, hypothyroid hyperprolactinemia
•6. Pregnancy, lactation or contraindication to pregnancy
•7. Current or past ( last 12 months) abuse of alcohol and drugs.
•8. Undiagnosed vaginal bleeding .
•9. Tumors of the ovary, breast, adrenal gland, pituitary or hypothalamus and malformation of sexual organs incompatible with pregnacy.
•10. Hypersensitivity to any trial product.

发起方

Bharat Serums and Vaccines Ltd